
Helix Medical, Inc.
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BLOM-SINGER SHOWER GUARD is an FDA 510(k)-cleared medical device (K904729) manufactured by Helix Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 27, 1991. Regulation: 8.

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